SBRT With DIBH for HCC After TACE and Lipiodol Marking

NCT05021250 | Unknown

• 1 other identifier: NCC2713
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Stereotactic Body Radiation Therapy (SBRT) for hepatocellular carcinoma (HCC) with radical dose achieved similar results with radiofrequency ablation (RF) and radical surgery, according to previous studies. For tumors near great blood vessels or with a diameter more than 2cm, SBRT performs even better than RF. In current clinical practice of SBRT for small HCC, registration is achieved by planting metal markers near the tumor, which has several disadvantages: 1. the operation is invasive, increase the risk of bleeding in patients with cirrhosis; 2. the operation is of no therapeutic value; 3. metal markers can only be planted outside the tumor to avoid transplantation, which compromises the accuracy of registration via CBCT. This study aims to adopt a new method of registration, transcatheter arterial chemoembolization (TACE) and lipiodol marking, to analyze the recognition and clarity of lipiodol on CBCT images, set-up errors and treatment efficacy. Therefore to provide data to support TACE and lipiodol marking over metal marker planting.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, TACE, SBRT, DIBH

Outcome Measures

Primary Outcomes (2)

• Recognition of lipiodol marking

  Judged by 2 technicians and 1 physician on CBCT images. High recognition is concluded when all three consider it easily registered. Moderate recognition is concluded when two consider it easily registered. Poor recognition is concluded when one or none consider it easily registered.

  During the radiotherapy

• ORR

  Objective response rate

  6 months after radiotherapy

Secondary Outcomes (4)

• Completion rate of treatment model

  1 months after TACE

• LCR

  12 months and 24 months after radiotherapy

• PFS

  12 months and 24 months after radiotherapy

• Frequency of AE

  up to 24 months

Study Arms (1)

Lipiodol marking

EXPERIMENTAL

HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH.

Procedure: Lipiodol marking

Interventions

Lipiodol marking PROCEDURE

HCC patients treated with TACE and the tumor marked with lipiodol.

Lipiodol marking

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically or pathologically confirmed hepatocellular carcinoma.
• ECOG 0-1.
• BCLC C
• Liver-GTV \>700ml; intrahepatic metastasis allowed but only one tumor is to be treated with SBRT and others stable for more than 3 months; distant metastasis allowed but stable for more than 6 months.
• Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f.
• DIBH training prior to SBRT to achieve 36 seconds breath hold.
• Life expectancy \> 3 months.
• Child-Pugh A5, A6 or B7.
• Liver function: ALT within 1.5 times of upper limit; ALT within 0.5 times of upper limit and AST within 6 times of upper limit, excluding cardiac infarction; ALT within 0.5-1.5 times of upper limit and AST within 1.5 times of upper limit
• Normal ECG, without severe cardiac dysfunction
• Kidney function: CRE, BUN within 1.5 times of upper limit.
• CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L
• Without hemorrhagic tendency.
• Voluntarily participate in this trial and sign consent form.

You may not qualify if:

• Participants of other clinical trials.
• History of abdomen radiation therapy or liver transplantation.
• History of severe cardiovascular, kidney or liver disease.
• Pregnancy or lactation.
• Suspected or confirmed of drug or alcohol abuse.
• History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis.
• Allergic to lipiodol.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• The First Hospital of Jilin University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Bo Chen

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Bo Chen

  National Cancer Center/Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: HCC patients treated with TACE and lipiodol marking, followed by SBRT with DIBH which was registrated with lipiodol.

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 25, 2021
• Study Start: July 21, 2021
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

CN (1)